About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. Patient Centricity is a guiding principle for action across staff and roles. We work closely with regulatory authorities and payers to ensure access to new therapies and to inform decisions with real-world evidence. Beyond medicines, we support stakeholder communities to improve awareness, education, access and standards of care.
The Opportunity
The QC Microbiologist will be responsible for supporting operations through completion of all testing required, including environmental monitoring of graded areas and clean utilities, product testing, report writing, procedure writing, and training. The role also includes responsibilities related to analytical method validation (technical transfer and pharmacopeial method validation).
Key Responsibilities
* Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in all tasks, including safety protocols.
* Oversee analytical technical transfers and qualification of Pharmacopeial methods for the laboratory.
* Manage environmental monitoring programs, product testing, trend reports, and related activities.
* Lead microbial testing training, troubleshoot instruments, and handle procedure/report writing.
* Author and update laboratory processes, manage incident reports, non-conformances, and CAPAs.
* Support cleanroom and aseptic process qualifications, participate in QC process improvement, and represent QC in cross-functional meetings.
Essential Knowledge & Experience
* Strong knowledge of Laboratory Information Management Systems (LIMS), SAP, Empower, and TrackWise.
* Extensive experience with instrumentation, including icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.
* Proficient in completing Pharmacopeial testing with a solid understanding of relevant standards.
Education
* B.S. degree in Microbiology with relevant industry experience in a Pharmaceutical Quality Control lab.
Additional Information
* This is a permanent full-time position.
* This position is based in Tralee – Ireland.
* This position requires you to be on site / in the office.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
Industries
* Pharmaceutical Manufacturing
#J-18808-Ljbffr